- The place of the Clinical Overview and Summary in lifecycle knowledge
from initial IB to PSUR, and how they support the changing SmPC

WHY YOU SHOULD ATTEND

The Common Technical Document Guideline is the obligatory format in the
EU and most territories worldwide for registration applications. This
meeting will present the regulatory guidelines and requirements, discuss
practical approaches to developing the content and preparation of the
Clinical Overview and Clinical Summaries (module 2) and provide an
update on the latest information and potential future developments.
Associated documents will also be discussed, such as the Risk Management
Plan and Summary of Product Characteristics.

WHO SHOULD ATTEND

Senior Research and Development Managers, members of Medical Science
Clinical Trial Departments, Medical Writers, Regulatory Affairs
personnel and all those interested in the Common Technical Document
Clinical Overview and Summary and its place in the continuum of evolving
clinical and safety knowledge about a product, and in the regulatory
approval process.

DOCUMENTATION

Participants will receive a course material folder containing
comprehensive documentation provided by the speaker, which will be a
valuable source of reference for the future.

ATTENDANCE LIMITED - EARLY REGISTRATION RECOMMENDED

This limitation, a unique feature of all the authors seminars, will give
participants the opportunity for a thorough discussion of the complex
issues to be covered by the programme.

A Certificate of Attendance for Professional Development will be given
to each participant who completes the course

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